NCT06310811

Anti-CD19 CAR-T Cell Therapy in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

Suspended NA Last updated 3 February 2026

What this trial tests

NA trial testing RD06-04 Cells injection in Safety in 12 participants. Suspended.

Timeline

7 March 2024

Primary endpoint
3 December 2026

1 March 2027

Quick facts

Lead sponsor	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Phase	NA
Status	Suspended
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	7 March 2024
Primary completion	3 December 2026
Estimated completion	1 March 2027
Sites	1 location across China

Drugs / interventions tested

• RD06-04 Cells injection — full drug profile →

Conditions studied

• Safety — all drugs for Safety →
• Effective — all drugs for Effective →

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Who can join

Adults 18 to 70, any sex, with Safety or Effective. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open, Phase I, investigator-initiated study (IIT) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with moderate or severe active SLE.

This study will explore the safety of escalating doses of RD06-04 by presetting two dose levels (DL), with 3 to 6 patients enrolled in each dose level. After safety conclusions are reached in each group, the investigator can select the corresponding dose group to expand cases based on treatment response, but the total number of cases will not exceed 12.

This study will enroll patients in a 3+3 design with two DLS: 1×105 CAR+T cells /kg for DL1 and 5×105 CAR+T cells /kg for DL2.

Dose increment Refer to the 3+3 dose increment principle. Three subjects are expected to be enrolled in each dose group.

1. Dose increment should start from the minimum dose, and it is not possible to conduct an incremental study of 2 or more dose groups at the same time.
2. If 1 case of DLT occurs in each dose group, the dose level will be extended to 6 subjects. If 6 subjects at this dose level ≥2 subjects develop DLT, the dose level exceeds the MTD. The previous lower dose level will be extended to 6 subjects, and if 6 subjects have already been enrolled in the previous lower dose level, and only ≤1 of these 6 subjects develop DLT, this lower dose level will be considered MTD.
3. If DLT occurred in ≥2 subjects in the highest dose group, the researcher could select a dose between the high dose group and the medium dose group according to the specific situation and perform MTD evaluation.
4. If the dose increase to the highest dose group still does not reach DLT, researchers can explore the safety and efficacy of higher doses according to specific circumstances.

Case expansion:

After the completion of DLT evaluation in all dose groups, the investigators could select the corresponding dose group of extended cases according to the treatment response, but the total number of cases should not exceed 12 (extended cases were not evaluated by DLT).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cutting-edge approaches to B-cell depletion in autoimmune diseases.
   Robinson WH, Fiorentino D, Chung L, Moreland LW, et al · · 2024 · cited 24× · PMID 39445025 · DOI 10.3389/fimmu.2024.1454747
2. Application of novel CAR technologies to improve treatment of autoimmune disease.
   Cheever A, Kang CC, O'Neill KL, Weber KS. · · 2024 · cited 18× · PMID 39445021 · DOI 10.3389/fimmu.2024.1465191
3. Current advancements in cellular immunotherapy for autoimmune disease.
   Berry CT, Frazee CS, Herman PJ, Chen S, et al · · 2025 · cited 15× · PMID 39821376 · DOI 10.1007/s00281-024-01034-5
4. CAR T-cell therapy in autoimmune diseases: a promising frontier on the horizon.
   Wu D, Xu-Monette ZY, Zhou J, Yang K, et al · · 2025 · cited 9× · PMID 40873568 · DOI 10.3389/fimmu.2025.1613878
5. Advances in engineered T cell immunotherapy for autoimmune and other non-oncological diseases.
   Huang Q, Zhu X, Zhang Y. · · 2025 · cited 7× · PMID 39901288 · DOI 10.1186/s40364-025-00736-8
6. CAR-T-Cell Therapy for Systemic Lupus Erythematosus: A Comprehensive Overview.
   Abdalhadi HM, Chatham WW, Alduraibi FK. · · 2024 · cited 7× · PMID 39408836 · DOI 10.3390/ijms251910511
7. Innovations in immunotherapy for autoimmune diseases: recent breakthroughs and future directions.
   Alsayb MA. · · 2025 · cited 2× · PMID 41041324 · DOI 10.3389/fimmu.2025.1647066
8. Research progress on chimeric antigen receptor-based immunotherapy against autoimmune diseases.
   Jiang M, Zhao J, Yuan J, Yu Z, et al · · 2025 · cited 2× · PMID 40747591 · DOI 10.1080/21645515.2025.2538350